triamterene and hydrochlorothiazide (82868-006)

Drug Facts

Product Profile

Brand Name triamterene and hydrochlorothiazide

Generic Name triamterene and hydrochlorothiazide

Labeler northwind health company, llc

Dosage Form TABLET

Routes

ORAL

Active Ingredients

hydrochlorothiazide 25 mg/1, triamterene 37.5 mg/1

Manufacturer

Northwind Health Company, LLC

Identifiers & Regulatory

Product NDC 82868-006

Product ID 82868-006_46dc8d44-ebc1-6013-e063-6294a90a11f7

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA216211

Listing Expiration 2026-12-31

Marketing Start 2023-08-18

Pharmacologic Class

Established (EPC)

thiazide diuretic [epc] potassium-sparing diuretic [epc]

Chemical Structure

thiazides [cs]

Physiologic Effect

increased diuresis [pe] decreased renal k+ excretion [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82868006

Hyphenated Format 82868-006

Supplemental Identifiers

RxCUI

310812

UNII

0J48LPH2TH WS821Z52LQ

NUI

N0000175359 N0000175419 M0471776 N0000008859 N0000175418

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name triamterene and hydrochlorothiazide (source: ndc)

Generic Name triamterene and hydrochlorothiazide (source: ndc)

Application Number ANDA216211 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

25 mg/1
37.5 mg/1

source: ndc

Packaging

30 TABLET in 1 BOTTLE, PLASTIC (82868-006-30)
90 TABLET in 1 BOTTLE, PLASTIC (82868-006-90)

source: ndc

Packages (2)

82868-006-30 30 TABLET in 1 BOTTLE, PLASTIC (82868-006-30) 82868-006-90 90 TABLET in 1 BOTTLE, PLASTIC (82868-006-90)

Ingredients (2)

hydrochlorothiazide (25 mg/1) triamterene (37.5 mg/1)

Linked Drug Pages (1)

Triamterene and Hydrochlorothiazide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "46dc8d44-ebc1-6013-e063-6294a90a11f7", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776", "N0000008859", "N0000175418"], "unii": ["0J48LPH2TH", "WS821Z52LQ"], "rxcui": ["310812"], "spl_set_id": ["03b11335-2e88-2f7b-e063-6394a90afe2a"], "pharm_class_cs": ["Thiazides [CS]"], "pharm_class_pe": ["Increased Diuresis [PE]", "Decreased Renal K+ Excretion [PE]"], "pharm_class_epc": ["Thiazide Diuretic [EPC]", "Potassium-sparing Diuretic [EPC]"], "manufacturer_name": ["Northwind Health Company, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (82868-006-30)", "package_ndc": "82868-006-30", "marketing_start_date": "20230818"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (82868-006-90)", "package_ndc": "82868-006-90", "marketing_start_date": "20230825"}], "brand_name": "Triamterene and Hydrochlorothiazide", "product_id": "82868-006_46dc8d44-ebc1-6013-e063-6294a90a11f7", "dosage_form": "TABLET", "pharm_class": ["Decreased Renal K+ Excretion [PE]", "Increased Diuresis [PE]", "Increased Diuresis [PE]", "Potassium-sparing Diuretic [EPC]", "Thiazide Diuretic [EPC]", "Thiazides [CS]"], "product_ndc": "82868-006", "generic_name": "Triamterene and Hydrochlorothiazide", "labeler_name": "Northwind Health Company, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Triamterene and Hydrochlorothiazide", "active_ingredients": [{"name": "HYDROCHLOROTHIAZIDE", "strength": "25 mg/1"}, {"name": "TRIAMTERENE", "strength": "37.5 mg/1"}], "application_number": "ANDA216211", "marketing_category": "ANDA", "marketing_start_date": "20230818", "listing_expiration_date": "20261231"}